Frequently Asked Questions

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General

microMend is a primary skin closure device used to close surgical incisions or lacerations. It can be applied with or without sutures or staples to close superficial wounds that are under minimal tension. microMend can also be used as an adjunct to close the skin layer after suture or staple closure of underlying tissue in high-tension wounds or those that extend beneath the upper dermis. It is also indicated for incision reinforcement for wounds after early suture or staple removal.

Location: microMend has the capability to be used to close wounds in all areas of the body. It is best suited for closing wounds on flat surfaces, such as the trunk (chest and back) and extremities. microMend should not be used to close wounds over areas of tension/flexion, such as knees or elbows.

Small surface areas: Due to its size, microMend is not suitable for use on the face, fingers, and toes in most cases.

Depth: microMend can be used alone to close wounds that extend through the upper dermis. For deeper dermal or subcutaneous wounds, subcutaneous sutures/staples should be combined with microMend closure on the skin surface.

Length: microMend is designed to close wounds of any length. Multiple devices are required to close longer wounds.

Wound type: microMend is ideally suited for closing linear wounds, but can also be used to close curved wounds. It is not recommended for closing jagged or irregular wounds.

There is extensive pre-clinical porcine data and clinical results documenting the excellent outcomes obtained with microMend.

5 porcine studies in which a total of over 90 full thickness skin wounds of varying length (1 to 12 cm.) were closed with microMend devices. Excellent wound closure results were documented in all wounds (see Clinical). There was no occurrences of infection, inflammation, wound dehiscence or other complications.

Clinical study performed in 18 patients undergoing laparoscopic or robotic surgery in which port site wounds (3-5 per patient) were closed with either microMend or sutures (control) in each patient (see Clinical). Patients and surgeons in the study overwhelmingly preferred the performance of microMend to sutures, and rated microMend cosmetic outcomes superior.

Areas of high-tension or repetitive motion, such as incisions that cross joint lines.

Areas where attachment of microMend to the skin cannot be obtained, due to the presence of hair, exudate, blood, oily skin, excess moisture, or certain dermatologic conditions (e.g., psoriatic lesions, eczema).

Note: persons with known allergy to skin adhesives should not use the device.

Tissue adhesive requires more time to use (30 seconds to 2 minutes compared to only seconds with microMend). There is an increased risk of wound dehiscence, especially if excess moisture is present. Once wounds are closed using tissue adhesives, the skin cannot be repositioned if closure is suboptimal. microMend can be easily removed and replaced if adequate closure is not achieved. If tissue adhesive enters the wound, it can lead to significant irritation/inflammation, which does not occur with microMend.

microMend has tiny skin gripping microstaples which penetrate into the dermis making it possible to oppose and close dermal wounds. Bandages are not designed to close these deeper skin wounds. microMend has stronger holding power provided by microstaples, which also enables the device to stay in place over the healing continuum. In contrast, bandages are prone to creep and ultimately fail as the adhesive loses strength over time. This can lead to re-opening of the wound.

After surgical incisions are closed, they are usually covered with a sterile absorbent dressing for 24 to 48 hours. Covering the wound may also be indicated in the following situations: sites subject to friction or rubbing; easily soiled sites; during showering; in a patient who might pick at the wound site.

The decision to use and when to use a dressing is up to your healthcare provider.

Never place adhesive tape or adhesive areas of a cover dressing directly over microMend. It creates a risk of loosening or pulling the device off when a dressing is removed or changed.

Patient may take showers, but should minimize exposure of the wound to water. To achieve this, it is recommended that the entire wound area be covered with a non-adhesive (gauze) dressing or waterproof (plastic) cover for showering.

The microMend site and surrounding area should never come into direct contact with shower spray.

After showering, carefully remove any protective cover materials, and gently pat the wound area until dry.

Use of creams and other products that contain moisture is a decision for the healthcare provider; it is recommended that they be avoided unless absolutely necessary. Patients should not apply any products at the wound site without approval from their provider.

The surfaces to which microMend is applied should be clean and dry prior to application.

microMend is designed to adhere to dry skin, and to allow drainage of exudate through the device without compromising its integrity after secure attachment to the skin is obtained during application.

In case of fluid accumulation beneath a microMend device, carefully remove microMend and apply a new device.

Absorptive dressings (such as gauze) should be changed as needed so that microMend is not in contact with the saturated dressing material for prolonged periods of time. Cover dressings that absorb and lock in exudate are recommended.

The patient should wear microMend for the entire time frame recommended by their healthcare provider. Wear time varies depending on the care of the skin closure, location of the incision and patient skin type.

If there is increased discomfort or if the wound area becomes reddened or excessively warm to touch, the patient should consult their healthcare provider. This may be a sign of an infection.

If the edges of microMend lift off the skin surface and/or the device will not reattach, trim the edge back to where the bandage holds. Doing this may prevent loss of the device due to catching on clothing or other objects.

If microMend detaches from the wound site earlier than the number of days recommended, contact your health care provider.

If microMend remains in place beyond the recommended treatment time or more than 14 days, patients should seek the advice of their health care provider.

miroMend’s microstaples produce tiny puncture wounds in the skin. They are much smaller than those that occur with sutures or staples. Limited redness may also be noticed where the microMend devices were applied to the skin. These tiny puncture wounds and redness should resolve within a few days after the device is removed. If they do not, your healthcare provider should be contacted.

microMend Device

After entering the skin, the microMend’s microstaples anchor to the underlying tissue and keep the wound closed. The microstaples are at a slight angle to the skin surface, which helps prevent microMend from pulling off the skin from movement or pressure due to fluid in underlying tissues.

KitoTech Medical is a Seattle-based medical device company that has developed microMend, a unique wound closure device. The product is an FDA Class 1 medical device listed with FDA and available for sale in the United States. Clinical studies are demonstrating outstanding clinical results and strong physician and patient preferences for microMend over sutures for closing wounds.